Safety and efficacy of misoprostol orally and vaginally: a randomized trial.

OBJECTIVE: To compare the safety and efficacy accompanying oral and vaginal misoprostol for cervical ripening. METHODS: One thousand four women with medical or obstetric indications for labor induction and unripe cervices were randomly assigned to receive oral or vaginal misoprostol. Initial doses of 200 microg oral and 50 microg vaginal misoprostol were increased to 300 microg oral and 100 microg vaginal after two doses, to a maximum of six doses. Misoprostol was given every 6 hours in both groups. We anticipated that 11% of women treated vaginally would require intervention during the ripening process. Intervention was defined as interruption of the ripening process before labor or Bishop score of 7 or a lack of response to six misoprostol doses. RESULTS: Five hundred three subjects were assigned to oral and 501 to vaginal administration. Oral misoprostol was associated with significantly higher frequencies of intervention (67 [13.3%] versus 42 [8.4%], P =.01), tachysystole (114 [23.6%] versus 85 [17.6%], P =.02), and hyperstimulation (90 [18.6%] versus 66 [13.7%], P =.04). There were no significant differences in cesarean rates (147 [29.2%] versus 120 [24.0%], P =.06), mean number of misoprostol doses used (1.5 versus 1.6, P =.18), or hours from drug administration to delivery (24.5 versus 25.4, P =.77) between the oral and vaginal groups, respectively. The numbers of deliveries between the groups within 24 hours was different (271 [56%] versus 290 [60%], P =.02), oral and vaginal, respectively. No adverse neonatal outcomes were noted. CONCLUSION: Oral misoprostol has similar efficacy as vaginal misoprostol but is associated with a higher frequency of excessive uterine contractility and intervention.     

Excessive uterine activity accompanying induced labor

OBJECTIVE: To estimate the incidence and timing of excessive uterine activity accompanying induction of labor with misoprostol using different routes (oral or vaginal) and forms (intact tablet or crushed) and to compare these with dinoprostone gel, oxytocin, and spontaneous labor. METHODS: This retrospective cohort study included 519 women at term who had labor induced and 86 women at term in spontaneous labor. Induction agents included misoprostol, dinoprostone, or oxytocin. Fetal heart rate and uterine activity tracings were analyzed independently by three maternal-fetal medicine physicians. The diagnosis of tachysystole or hyperstimulation required the agreement of two or more reviewers. RESULTS: The incidence of tachysystole was highest with misoprostol administered by vaginal tablet (misoprostol vaginal tablet 50 microg every 4 hours, 48.6%; vaginal tablet crushed 50 microg and suspended in hydroxyethyl gel every 4 hours, 30.7%, P =.009; oral tablet 50 microg every 4 hours, 22.2%, P =.001; oral tablet crushed 50 microg every 4 hours, 15.5%, P <.001; dinoprostone gel, 33.0%, P =.022; intravenous oxytocin, 30.2%, P =.027; and spontaneous onset of labor, 23.3%, P <.001). Hyperstimulation occurred more often with dinoprostone gel (16.5%) than with other forms of induction or spontaneous labor. Hyperstimulation occurred significantly more often with vaginal misoprostol crushed tablet (7.9%) and vaginal misoprostol intact tablet (7.6%) than with crushed oral misoprostol (1.0%) (P =.016 and.018, respectively). There was a shorter time to tachysystole with increasing doses of vaginal misoprostol tablet (P =.01). CONCLUSION: The incidence of tachysystole and hyperstimulation, and time to tachysystole, varied depending on the route and form of misoprostol given.     

Oral misoprostol or vaginal dinoprostone for labor induction: a randomized controlled trial

OBJECTIVE: The objective of the study was to compare the effectiveness, safety, and side effects of low-dose oral misoprostol with vaginal dinoprostone for cervical ripening and labor induction. STUDY DESIGN: Women with Bishop score 6 or less admitted for labor induction at term were eligible for this randomized controlled trial. Exclusion criteria were multiple pregnancy, breech, fetal distress, or previous uterine scar. The allocation to the oral misoprostol group (20 microg given every 2 hours increased to 40 microg depending on uterine contractions) or to the vaginal dinoprostone group (2 mg twice, 6 hours apart) was contained in a sealed, opaque, and consecutively numbered envelope. RESULTS: Two hundred women (100 in each group) were included. The proportion of vaginal delivery within 24 hours was 56% in the misoprostol group and 62% in the dinoprostone group (relative risk 0.90, 95% CI 0.72-1.14). The risk of cesarean section was 18% and 19%, respectively. The median interval to delivery, calculated from survival analysis, was longer in the misoprostol group (1305 minutes) compared with the dinoprostone group (1080 minutes). The log-rank test was not significant (P =.35). Uterine hyperstimulation occurred in 9% of women in the misoprostol group compared with 14% in the dinoprostone group (P =.27). The only significant difference in neonatal outcomes was a more frequent presence of thick meconium in the misoprostol group (P =.03). CONCLUSION: We found no difference in terms of effectiveness and safety between low-dose oral misoprostol and vaginal dinoprostone used for induction of labor. This regimen avoids the excessive uterine contractility noted in previous studies, where higher doses of misoprostol were administered at longer intervals.     

Cervical ripening and induction of labor with misoprostol,dinoprostone gel,and a Foley catheter: a randomized trial of 3 techniques

OBJECTIVE: The purpose of this study was to compare the efficacy of 3 different techniques of cervical ripening and induction. STUDY DESIGN: Patients who required cervical ripening and induction were randomized to one of 3 groups: (1) supracervical Foley catheter and intravaginal dinoprostone gel, (2) supracervical Foley catheter and 100 microg oral doses of misoprostol, or (3) serial 100-microg oral doses of misoprostol. Intravenous oxytocin was administered when a protraction disorder of labor was identified. RESULTS: There were 339 women randomized. There was no significant difference in the time from first intervention to delivery in the 3 groups (P =.546). In each group, a similar percentage of women required oxytocin (P =.103). The rates of cesarean delivery were equivalent among the groups (P =.722). Rates of tachysystole were high but statistically equivalent among the 3 groups. There were no significant differences in Apgar scores or umbilical artery pH. CONCLUSION: Oral 100 microg serial doses of misoprostol, with or without the use of a supracervical Foley catheter, were equivalent to the use of a supracervical Foley catheter and serial 4-mg doses of dinoprostone gel for cervical ripening and the induction of labor.     

A comparison of orally administered misoprostol with vaginally administered misoprostol for cervical ripening and labor induction.

OBJECTIVE: Our purpose was to compare orally administered with vaginally administered misoprostol for cervical ripening and labor induction. MATERIAL AND METHODS: Two hundred twenty subjects with medical or obstetric indications for labor induction and undilated, uneffaced cervices were randomly assigned to receive orally administered or vaginally administered misoprostol. Fifty micrograms of oral misoprostol or 25 microgram of vaginal misoprostol was given every 4 hours. If cervical ripening (Bishop score of >/=8 or cervical dilatation of >/=3) or active labor did not occur, repeated doses were given to a maximum of 6 doses or 24 hours. Thereafter, oxytocin was administered intravenously by a standardized incremental infusion protocol to a maximum of 22 mU/min. RESULTS: Of the 220 subjects evaluated, 110 received orally administered misoprostol and 110 received vaginally administered misoprostol. Fewer subjects who received the oral preparation (34/110, 30.9%) were delivered vaginally within 24 hours of initiation of induction, in comparison with those who received the vaginal preparation (52/110, 47.3%) (P =.01). The average interval from start of induction to vaginal delivery was nearly 6 hours longer in the oral treatment group (mean and SD 1737.9 +/- 845.7 minutes) than in the vaginal treatment group (mean and SD 1393.2 +/- 767.9) (P =.005, log-transformed data). Orally treated patients required significantly more doses than vaginally treated patients (orally administered doses: mean and SD 3.3 +/- 1.7; vaginally administered doses: mean and SD 2.3 +/- 1.2) (P <.0001). Oxytocin administration was necessary in 83 (75.4%) of 110 orally treated subjects and in 65 (59.1%) of 110 vaginally treated subjects (P =.01, relative risk 1. 28, 95% confidence interval 1.06-1.54). Vaginal delivery occurred in 95 (86.4%) orally treated subjects and in 85 (77.3%) vaginally treated subjects (P =.08, relative risk 1.12, 95% confidence interval 0.99-1.27), with the remainder undergoing cesarean delivery. There was no difference in the incidence of uterine contractile abnormalities (tachysystole, hypertonus, or hyperstimulation), intrapartum complications, or neonatal outcomes between the 2 groups. CONCLUSIONS: Oral administration of 50-microgram doses of misoprostol appears less effective than vaginal administration of 25-microgram doses of misoprostol for cervical ripening and labor induction. Further investigation is needed to determine whether orally administered misoprostol should be used for cervical ripening and labor induction.     

Oral versus vaginal misoprostol for labor induction

OBJECTIVE: To compare the safety and effectiveness of vaginal with oral misoprostol for induction of labor. METHODS: A total of 107 women with clinical indication for induction were randomly assigned to receive oral or vaginal misoprostol. Doses of 100 microg of oral or 25 microg of vaginal misoprostol were given every 3-4 hours. If cervical ripening or active labor did not occur, repeated doses of oral (100-200 microg) or vaginal (25-50 microg) were given until labor was established. RESULTS: Fifty-nine women received oral misoprostol, and 48 received vaginal administration. Delivery time was similar for the vaginal and oral arms (1074 +/- 488 minutes versus 930 +/- 454 minutes, P =.11). Parity was significantly different (P =.04) for the vaginal and oral groups. The cesarean delivery rate was similar for the vaginal and oral arms (17% versus 15%, P =.72). The number of medication administrations was consistent between groups. Birth weight was not different for patients in the control and treatment groups (vaginal 3281 +/- 507 g versus oral 3359 +/- 541 g, P =.44). Chorioamnionitis and tachysystole were comparable for the oral and vaginal groups. There was no statistical difference in neonatal outcomes. Similar proportions of infants were admitted to the well baby nursery and intermediate care nursery. CONCLUSION: These findings indicate that, in a closely supervised hospital setting with adequate monitoring, oral misoprostol has the potential to induce labor as safely and effectively as its vaginal analogue.     

Cardiotocographic abnormalities associated with dinoprostone and misoprostol cervical ripening

OBJECTIVE: To characterize the frequency and timing of cardiotocographic abnormalities associated with the use of 3 commercially available prostaglandin analogues, misoprostol, dinoprostone gel, and dinoprostone pessary, as labor preinduction agents. METHODS: One-hundred and eleven women undergoing induction of labor with an unfavorable cervix were randomized to receive either misoprostol 50 microg every 6 hours x 2 doses, dinoprostone gel 0.5 mg every 6 hours x 2 doses, or dinoprostone pessary 10 mg x 1 dose for 12 hours intravaginally. Oxytocin induction was initiated per standardized protocol. Cardiotocographic tracings were blindly reviewed, with abnormalities coded using established definitions. RESULTS: Fifty-five percent of women treated with misoprostol demonstrated an abnormal tracing event within the initial 24 hours of induction, compared with 21.1% with dinoprostone pessary and 31.4% with the dinoprostone gel. The mean (+/- standard deviation) number of abnormal events was significantly greater in women treated with misoprostol (5.0 +/- 5.9) versus the dinoprostone pessary (1.6 +/- 2.5) and gel (2.2 +/- 3.1) (P < .05). In addition, these events occurred earlier after initial misoprostol dosing (5.0 +/- 4.0 hours), compared with the dinoprostone pessary (9.4 +/- 5.6 hours) and gel (7.7 +/- 6.6). Thirty-nine percent of the misoprostol-treated women had abnormal patterns within 6 hours of initial dosing, compared with those treated with the dinoprostone pessary (7.9%) and gel (17.1%). CONCLUSION: Cardiotocographic abnormalities are more frequent after misoprostol administration compared with the dinoprostone analogues. The early onset and frequent nature of the tracing abnormalities associated with misoprostol raises concern for the potential use of misoprostol for outpatient cervical ripening.     

Comparative efficacy and cost of the prostaglandin analogs dinoprostone and misoprostol as labor preinduction agents

OBJECTIVE: The purpose of this study was to compare the relative efficacy and cost of three commercially available prostaglandin analogs, misoprostol (Cytotec), dinoprostone gel (Prepidil), and dinoprostone insert (Cervidil), as labor preinduction agents. STUDY DESIGN: One-hundred eleven women with an unfavorable cervix who underwent labor induction were assigned randomly to receive either misoprostol 50 microg every 6 hours for two doses, dinoprostone gel 0.5 mg every 6 hours for two doses, or dinoprostone insert 10 mg for one dose intravaginally. Twelve hours later, oxytocin induction was initiated per standardized protocol. Efficacy and cost of the labor preinduction/induction with the study treatments were compared. RESULTS: Mean Bishop score change (+/-SD) over the initial 12-hour interval was significantly greater in the misoprostol group (5.2 +/- 3.1) compared with the dinoprostone insert (3.2 +/- 2.3) or the dinoprostone gel groups (2.2 +/- 1.3, P <.0001). The proportion of women who reached complete dilation (68.4%, 50.0%, 51.4%, respectively; P =.14) and who were delivered (60.5%, 47.4%, 40.0%, respectively; P =.10) within 24 hours of the initiation of induction were not significantly different between the misoprostol, dinoprostone insert, and dinoprostone gel groups. Induction-to-delivery intervals, however, were significantly shorter among women who treated with misoprostol (24.0 +/- 10.8 hours) compared with either the dinoprostone gel (31.6 +/- 13.4 hours) or the dinoprostone insert (32.2 +/- 14.7 hours, P <.05). Overall mean cost per patient that was incurred by labor induction was significantly less for the misoprostol group ($1036.13) compared with the dinoprostone insert group ($1565.72) or the dinoprostone gel group ($1572.92, P <.0001). No significant differences were noted with respect to the mode of delivery or to the adverse maternal/neonatal outcome. CONCLUSION: Misoprostol is more cost-effective than the comparable commercial dinoprostone prostaglandin preparations as an adjuvant to labor induction in women with an unfavorable cervix.     

Misoprostol and dinoprostone therapy for labor induction: a Doppler comparison of uterine and fetal hemodynamic effects

OBJECTIVE: To compare the effect of misoprostol (PGE(1)) versus dinoprostone (PGE(2)) on blood flow in uteroplacental circulation during labor induction. STUDY DESIGN: Eighty-four women with indications for induction of labor were assigned to receive either misoprostol 50 microg per vagina every 4 h as needed or 0.5 mg doses of dinoprostone given intra-cervically every 6 h by means of a randomization table generated by computer. Doppler velocimetry of umbilical, uterine and arcuate arteries was performed immediately before and 2-3 h after the administration of misoprostol or dinoprostone. The SAS system was used to perform statistical analysis. RESULTS: There were no significant changes of pulsatility index (PI), resistance index (RI) and systolic/diastolic (S/D) ratio in umbilical arteries after both prostaglandin compounds. Vaginal application of misoprostol significantly increased all ratios in arcuate artery and S/D ratio in uterine artery. Intra-cervically dinoprostone significantly increased PI, RI and S/D ratio in arcuate and uterine arteries. CONCLUSIONS: Our results indicate that vaginal misoprostol and cervical dinoprostone administration increases uteroplacental resistance but does not affect umbilical blood flow. Misoprostol would be as safe and effective agent as dinoprostone for cervical ripening and labor induction.     

Effect of vaginal pH on efficacy of the dinoprostone gel for cervical ripening/labor induction

OBJECTIVE: The purpose of this study was to evaluate whether vaginal pH has an effect on the efficacy of the dinoprostone gel for cervical ripening/labor induction. STUDY DESIGN: Thirty-two women with an unfavorable cervix who were undergoing labor induction were enrolled in this prospective, double-blinded investigation. Initial vaginal pH and Bishop score assessment were made by an independent examiner. All women received cervical ripening with the dinoprostone gel 5 mg intracervically, with repeated dosing one time 6 hours later. Twelve hours later, oxytocin induction was initiated per standardized protocol, and outcome data were collected. RESULTS: Mean (+/-SD) initial vaginal pH was 4.7 +/- 0.6 (range, 4.0-6.0) for the study cohort. No significant differences were noted between women with a high vaginal pH (>4.5, n = 16 women) and women with a low vaginal pH (< or =4.5, n = 16 women) with respect to maternal age, parity, gestational age, or initial Bishop score. Although Bishop score change over the initial 12 hours of cervical ripening did not significantly differ between the high vaginal pH (2.3 +/- 2.3) and the low vaginal pH group (2.3 +/- 2.5, P = not significant), time to active labor (19 +/- 10 hours vs 33 +/- 17 hours, P =.001), complete dilation (24 +/- 10 hours vs 37 +/- 19 hours, P =.03), and delivery (26 +/- 10 hours vs 38 +/- 18 hours, P =.02) were significantly shorter in women with a high vaginal pH compared with women with a low vaginal pH, respectively. A significant association was noted between vaginal pH and time to active labor (r = -0.52, P =.003), complete dilation (r = -0.50, P =.006), and delivery (r = -0.44, P =.01); however, pH was not significantly associated with Bishop score change during the initial 12 hours of cervical ripening. CONCLUSION: Vaginal pH is an important factor that affects the efficacy of the dinoprostone gel as an adjuvant for labor induction.     

Vaginally administered misoprostol for outpatient cervical ripening in pregnancies complicated by diabetes mellitus

OBJECTIVE: To compare the use of vaginally administered misoprostol to placebo for outpatient labor induction in patients with diabetes. STUDY DESIGN: In this double-masked, controlled clinical trial, pregnant women with diabetes and gestational age of >38(1/2) weeks were randomized to receive 25 microg misoprostol or placebo vaginally on days 1 and 4 of a 7-day outpatient cervical ripening period. If necessary, inpatient labor induction was managed by using a standard protocol. RESULTS: Of 120 women included in the study, 57 received misoprostol and 63 received placebo. Most of the women had been diagnosed with gestational (Class A) diabetes. Similar numbers of misoprostol and placebo-treated women delivered within 7 days of the first dose (31/57 [54%] vs 36/63 [57%], P =.63). The mean (+/-SEM) interval from induction to delivery was similar (8530.5 minutes +/-1439.7 minutes vs 6712.5 minutes +/-606.4 minutes, P =.23). CONCLUSION: Vaginally administered misoprostol was no more effective than placebo in reducing the need for inpatient labor induction or the induction-delivery interval. Outpatient cervical ripening with use of vaginally administered misoprostol was well tolerated.     

Labor induction with prostaglandin E1 misoprostol compared with dinoprostone vaginal insert: A randomized trial

Objective: To compare the safety, efficacy, and costs of intravaginal misoprostol versus dinoprostone vaginal inserts for cervical ripening and labor induction.Methods: Two hundred twenty-three labor induction patients were assigned randomly to one of two treatment groups: 1) intravaginal misoprostol or 2) dinoprostone vaginal inserts. Fifty micrograms of misoprostol were placed in the posterior vaginal fornix every 3 hours for a maximum period of 24 hours. Ten milligrams of dinoprostone was administered in a single application as a vaginal insert for 12 hours.Results: Among 223 patients evaluated, 108 were allocated to the misoprostol group and 115 to the dinoprostone group. The median interval from induction to vaginal delivery was significantly shorter in the misoprostol group: 698 (range 395–1053) versus 1041 (range 792–1531) minutes (P < .001). Vaginal delivery within 12 hours of ripening occurred in 40.7% of patients who received misoprostol compared with 19.1% for those receiving dinoprostone (P < .001); no significant difference between the groups was noted for vaginal delivery within 24 hours. Uterine tachysystole occurred more frequently in patients in the misoprostol group (21.3%) than in the dinoprostone group (7.0%) (P = .004). Nevertheless, no statistically significant differences were noted between the groups with respect to intrapartum complications, including uterine hyperstimulation, mode of delivery, and neonatal or maternal adverse outcomes. The average cost per patient for misoprostol treatment was $85 compared with $606 for treatment with the vaginal insert.Conclusion: Intravaginal misoprostol and the dinoprosone vaginal insert appear to be safe agents for cervical ripening and labor induction. However, misoprostol is less expensive and more effective than the dinoprostone vaginal insert.     

Prospective randomized clinical trial of inpatient cervical ripening with stepwise oral misoprostol vs vaginal misoprostol

OBJECTIVE: The purpose of this study was to compare the efficacy and safety of stepwise oral misoprostol vs vaginal misoprostol for cervical ripening before induction of labor. STUDY DESIGN: Two hundred and four women between 32 to 42 weeks of gestation with an unfavorable cervix (Bishop score < or = 6) and an indication for labor induction were randomized to receive oral or vaginal misoprostol every 4 hours up to 4 doses. The oral misoprostol group received 50 microg initially followed by 100 microg in each subsequent dose. The vaginal group received 25 microg in each dose. The primary outcome was the interval from first misoprostol dose to delivery. Patient satisfaction and side effects were assessed by surveys completed after delivery. RESULTS: Ninety-three (45.6%) women received oral misoprostol; 111 (54.4%) received vaginal misoprostol. There was no difference in the average interval from the first dose of misoprostol to delivery in the oral (21.1 + 7.9 hrs) and vaginal (21.5 + 11.0 hrs, P = NS) misoprostol groups. The incidence of hyperstimulation in the oral group was 2.2% vs 5.4% in the vaginal group, P = NS. Eighteen patients in the oral group (19.4%) and 36 (32.4%) in the vaginal group underwent cesarean section (P < .05). This difference was attributed to better tolerance of more doses of misoprostol by the women in the oral group. There was no difference in side effects (nausea, vomiting, diarrhea, shivering) between groups. Fourteen percent of women in the vaginal group versus 7.5% in the oral group were dissatisfied with the use of misoprostol (P = NS). CONCLUSION: Stepwise oral misoprostol (50 microg followed by 100 microg) appears to be as effective as vaginal misoprostol (25 microg) for cervical ripening with a low incidence of hyperstimulation, no increase in side effects, a high rate of patient satisfaction, and is associated with a lower cesarean section rate.     

Mifepristone for preinduction cervical ripening beyond 41 weeks' gestation: a randomized controlled trial

OBJECTIVE: To compare the effect of mifepristone with placebo on cervical ripening before labor induction in prolonged pregnancies. METHODS: One hundred eighty women with pregnancies beyond 41 weeks and undilated, uneffaced cervices were assigned randomly to receive mifepristone 200 mg or placebo and observed for 24 hours. We then gave intravaginal misoprostol 25 microg every 4 hours or intravenous oxytocin. We expected 60% of placebo-treated and 80% of mifepristone-treated women to deliver vaginally within 48 hours. RESULTS: Among 180 subjects, 97 received mifepristone and 83 received placebo. The mean interval (+/- standard deviation [SD]) from start of induction to delivery was 2209 +/- 698 minutes for mifepristone-treated subjects and 2671 +/- 884 minutes for placebo-treated subjects (P <.001, log-transformed data). Twelve (13. 6%) mifepristone-treated women and seven (10.8%) placebo-treated women delivered vaginally on day 1 (P =.60). After 24 hours, the median Bishop score for both groups was 3 (0-11) (P =.51). One hundred thirty-one subjects required misoprostol, 65 (67.0%) were mifepristone-treated women, and 66 (79.5%) placebo-treated women (P =.06). The median (range) oxytocin dose was 871.5 (0-22,174) mU for mifepristone-treated women and 2021.0 (0-24,750) mU for placebo-treated women (P =.02). Seventy-seven (87.5%) mifepristone-treated women and 46 (70.8%) placebo-treated women delivered vaginally 48 hours after the start of treatment (P =.01). There were nine cesareans in the mifepristone group and 18 in the placebo group (P =.02). More nonreassuring fetal heart rate patterns and uterine contractile abnormalities occurred in mifepristone-treated subjects. There were no statistically significant differences in neonatal outcomes between groups. CONCLUSION: Mifepristone had a modest effect on cervical ripening when given 24 hours before labor induction, appearing to reduce the need for misoprostol and oxytocin compared with placebo.     

Misoprostol: An effective agent for cervical ripening and labor induction

Objective: Our purpose was to compare the safety and efficacy of intravaginal misoprostol versus intracervical prostaglandin E₂ gel (dinoprostone) for preinduction cervical ripening and induction of labor.Study design: Two hundred seventy-six patients with indications for induction of labor and unfavorable cervices were randomly assigned to receive either intravaginal misoprostol or intracervical dinoprostone. Twenty-five micrograms of misoprostol were placed in the posterior vaginal fornix every 3 hours, with a potential maximum of eight doses. Prostaglandin E₂ in gel form, 0.5 mg, was placed in the endocervix every 6 hours, with a maximum of three doses. Further medication was withheld with the occurence of spontaneous rupture of membranes, entry into active phase of labor, or a “prolonged contraction response.”Results: Among those evaluated, 138 received misoprostol and 137 received dinoprostone. The average interval from start of induction to vaginal delivery was shorter in the misprostal group (1323.0 ± 844.4 minutes) than in the dinoprostone group (1532.4 ± 706.5 minutes) (p < 0.05). Need for oxytocin augmentation of labor occurred more commonly in the dinoprostone group (72.6%) than in the misprostol group (45.7%) (p < 0.0001). There were no significant differences in the routes of delivery. Twenty-eight of the misoprostol-treated patients (20.3%) and thirty-eight of the dinoprostone-treated patients (27.7%) required abdominal delivery. Complications such as uterine lachysystole and thick meconium passage occurred with similar frequency in the two treatment groups.Conclusions: Intravaginal administration of misoprostol appears to be as effective as intracervical dinoprostone for cervical ripening and labor induction. Complications associated with prostaglandin administration were not statistically different between the two treatment groups. The cost of misoprostol ($0.36/100μg) is much less than that of dinoprostone ($75/0.5mg).     

Abruptio placentae associated with misoprostol use in women with preeclampsia

OBJECTIVE: To evaluate complications associated with cervical ripening with vaginal administration of misoprostol and dinoprostone vaginal inserts in women with preeclampsia. preeclampsia. STUDY DESIGN: Retrospective study of patients with preeclampsia undergoing cervical ripening with vaginal misoprostol and dinoprostone vaginal inserts prior to labor induction. RESULTS: Among 203 patients with preeclampsia undergoing cervical ripening prior to induction, 95 received vaginal misoprostol, and 108 received dinoprostone. The incidence of uterine hyperstimulation requiring medical therapy and the need for emergency cesarean section due tofetal heart rate abnormalities were significantly higher among patients receiving misoprostol (22.1% versus 12.0%, p = 0.04, and 17.9% versus 8.3%, p = 0.03, respectively). The overall incidence of abruptio placentae was 7.4%, with a significantly higher incidence among those receiving misoprostol as compared to dinoprostone (13.7% versus 1.9%, p = 0.001). CONCLUSION: Among patients with preeclampsia undergoing cervical ripening prior to labor induction, there is a higher incidence of acute intrapartum complications (uterine hyperstimulation, cesarean section for fetal heart rate abnormalities and abruptio placentae) with vaginal misoprostol, as compared to dinoprostone, vaginal insert.     

Outpatient misoprostol compared with dinoprostone gel for preinduction cervical ripening: a randomized controlled trial

OBJECTIVE: To determine whether a single outpatient dose of intravaginal misoprostol (versus intracervical dinoprostone gel) reduces the oxytocin use for induction. Despite the numerous trials examining misoprostol for induction, the efficacy of a single outpatient dose of misoprostol followed by oxytocin induction is unknown. METHODS: Patients with a term, vertex, singleton pregnancy and a Bishop score of 6 or less were randomly assigned to receive misoprostol (n = 42, 0.25 microg intravaginally) or dinoprostone gel (n = 42, 0.5 mg intracervically) the evening before oxytocin induction. Patients were monitored for 3 hours after administration and discharged to home if fetal assessment was reassuring, for readmission the next morning for oxytocin. Primary outcomes were oxytocin dose, time, and dose intensity (dose divided by duration). Secondary outcomes were incidence of labor, uterine hyperstimulation, cesarean delivery, Apgar score. Statistics used were chi(2), Student t test, Mann-Whitney rank sum test, and Fisher exact test. P < .05 was accepted as statistically significant. RESULTS: A single dose of misoprostol significantly decreased the cumulative dose of oxytocin, the cumulative time of oxytocin administration, and the dose intensity of oxytocin (dose divided by time). Data are as follows (mean +/- standard error of the mean): oxytocin dose-dinoprostone 10,929 +/- 219 mU, misoprostol 6,081 +/- 170 mU, P = .008; oxytocin time-dinoprostone 798 +/- 11 minutes, misoprostol 531 +/- 11 minutes, P = .009; dose intensity-dinoprostone 11.3 +/- 0.1 mU/min, misoprostol 7.4 +/- 0.2 mU/min, P = .003. Misoprostol induced labor during the ripening period in 19 of 41 of patients, compared with 6 of 42 after dinoprostone (P = .002). There was no difference in cesarean delivery (dinoprostone, 8/42; misoprostol, 9/42; P = 1.00). There was no difference in short-term neonatal outcome. No patient had hyperstimulation or required cesarean delivery for nonreassuring fetal assessment during the ripening period. CONCLUSION: A single dose of misoprostol administered in the outpatient setting significantly decreases oxytocin use, largely due to labor within the ripening period.     

A comparison of misoprostol and prostaglandin E2 gel for preinduction cervical ripening and labor induction

Objective: Our purpose was to compare the safety ad efficacy of intravaginal misoprostal versus intracervical prostaglandin E₂ (dinoprostone) gel for preinduction cervical ripening and induction of labor.Study design: One hundred thirty-five patients with indications for induction of labor and unfavorable cercices were randomly assigned to receive either intravaginal misoprostol or intracervical dinoprostate. Fifty microgram tablets of misoprostol were placed in the posterior vaginal fornix every 3 hours for a maximum of six doses. Prostaglandin E₂ in gel form, 0.5 mg, was placed into the endocervix every 6 hours for a maximum of three doses. Medication was not given after either spontaneous rupture of membranes or beginning of active labor.Results: Among 135 patients enrolled, 68 received misprostol and 67 dinoprostone. The average interval from start of induction to vaginal delivery was shorter in the misoprostol group (903.3 ± 482.1 minutes) than in the dinoprostone group (1410.9 ± 869.1 minutes) (p < 0.001). Oxytocin augmentation of labor occurred more often in the dinoprostone group (65.7%) than in the misoprostal group (33.8%) p < 0.001). There were no significant differences between routes of delivery. Ten of the misoprostol-treated patients (14.7%) and 13 of the dinoprostone-treated patients (19.4%) had cesarean deliveries. There was a higher prevalence of tachysystole (six or more uterine contractions in a 10-minute window for two consecutive 10-minute periods) in the misoprostol group (36.7%) than in the dinoprostone group (11.9%) (p < 0.001). However, there were no significant differences in frequency of uterine hyperstimulation or hypertonus. There was a higher prevalence of meconium passage in the misoprostol group (27.9%) than in the dinoprostone group (10.5%) (p < 0.05). Thee was no significant difference in frequency of abnormal fetal heart rate tracings, 1- or 5-minute Apgar scores <7, neonatal resuscitations, or admissions to the neonatal intensive care unit between the two groups.Conclusions: Vaginally administered misoprostol is an effective agent for cervical ripening and induction of labor; however when given at this dosage, it is associated with a higher prevalence of tachysystole and meconium passage than is dinoprostone. Further studies to compare the safety of misoprostol to that of dinoprostone and to delineate an optimal dosing regimen for misoprostol are needed.     

A comparison of vaginally administered misoprostol with extra-amniotic saline solution infusion for cervical ripening and labor induction

OBJECTIVE: The purpose of this study was to compare intravaginal misoprostol with extra-amniotic saline solution infusion with concomitant oxytocin for cervical ripening and labor induction in viable pregnancies. STUDY DESIGN: Two hundred women with indications for labor induction and unfavorable cervices were assigned randomly to vaginal misoprostol or extra-amniotic saline solution infusion. Twenty-five micrograms of misoprostol was administered every 4 hours up to six doses, followed by intravenous oxytocin administration. Patients who had received extra-amniotic saline solution infusion also received intravenous oxytocin along with a maximum 12-hour saline solution infusion through Foley catheters that were placed above the internal cervical os. RESULTS: One hundred women were randomly assigned to misoprostol, and 100 women were assigned randomly to extra-amniotic saline solution infusion. The average interval from start of induction to vaginal delivery was longer in the misoprostol group (1323.3 +/- 700.3 minutes) than in the extra-amniotic saline solution infusion group (970.4 +/- 502.7 minutes; P =.006, log transformed data). Abnormal fetal heart rate tracings were found in 30% of the patients who received misoprostol and in 19% of the patients who received extra-amniotic saline solution infusion (relative risk, 1.6; 95% CI, 1.0-2.4; P =.05). There was more tachysystole in the misoprostol group (8%) than in the extra-amniotic saline solution infusion group (1%; P =.02). There were no differences in the routes of deliveries or neonatal outcomes between groups. CONCLUSION: Extra-amniotic saline solution infusion with oxytocin administration appears more effective and is associated with fewer maternal complications than misoprostol for cervical ripening and labor induction.     

Factors affecting the likelihood of successful induction after intravaginal misoprostol application for cervical ripening and labor induction

OBJECTIVE: Our purpose was to determine whether maternal age, height and weight, parity, duration of pregnancy, cervical dilatation or Bishop score, and birth weight could be used to predict the likelihood of successful induction in women given intravaginal misoprostol. STUDY DESIGN: A computerized database was compiled of 1373 pregnancies in which intravaginal misoprostol was given for cervical ripening and labor induction. Most of these women were placed on investigational protocols in which the dose of misoprostol administered was 25 to 50 microg and the dosing intervals ranged from 3 to 6 hours. No more than 24 hours of administration was permitted. Induction was undertaken in women with unfavorable cervical examinations (Bishop scores of 4 or less) and without spontaneous labor or ruptured membranes. Univariate and stepwise multiple regression analyses were performed to identify those factors associated with successful induction, defined as vaginal delivery within 24 hours of induction. RESULTS: Six hundred fifty-seven (48%) had successful induction. Parity (odds ratio [OR] 2.5, 95% CI 2.0-2.9, P <.0001), initial cervical dilatation (OR 1.9, 95% CI 1.6-2.3, P <.0001), Bishop score (OR 1.6, 95% CI 1.3, 1.8, P <.0001), and gestational age at entry (OR 1.3, 95% CI 1.1-1.5, P =.002) were significant at the.05 level for predicting successful induction. A multivariate stepwise logistic regression was then performed to evaluate each of these as independent predictors. Parity (OR 2.4, 95% CI 2.0-3.0, P <.0001), initial cervical dilatation (OR 1.7, 95% CI 1.4-2.1, P <.0001), and estimated gestational age (OR 1.3, 95% CI 1.1-1.6, P =.003) are significant independent predictors for successful induction, but initial Bishop score is not significant (P =.19) after adjustment for other significant predicting factors. CONCLUSIONS: The clinical characteristics of parity, initial cervical dilatation, and gestational age at entry are predictors of the likelihood of success of cervical ripening and labor induction with intravaginal misoprostol administration.